Breast Cancer Survivors, Endocrine Therapy-Induced Joint Pain
Conditions
Brief summary
The purpose of this pragmatic, multicenter, randomized controlled trial is to evaluate the clinical effectiveness and safety of electroacupuncture and auricular acupressure for improving joint pain related to endocrine therapy in breast cancer patients. A total of 200 participants will be recruited and randomly assigned to one of three groups: the Electroacupuncture Group (n=80), the Auricular Acupressure Group (n=80), or the Waitlist Control Group (n=40), using a central stratified block randomization method. The primary objective is to compare changes in Worst Pain Item score among the three groups from baseline to the end of the treatment period, as measured by the Brief Pain Inventory-Short Form (BPI-SF). Secondary objectives include assessing pain interference, overall health status through the PROMIS scale, and quality of life specifically related to endocrine therapy using the FACT-ES. Additionally, the study will evaluate analgesic medication use (QAQ), patient expectations (Acupuncture Expectancy Scale), treatment adherence, and the occurrence of adverse events. By comparing these interventions, this study aims to generate high-quality evidence for the management of treatment-related arthralgia in breast cancer survivors.
Interventions
PROCEDUREElectroacupuncture Group
Electroacupuncture is performed using the basic prescription combined with the prescription for the affected joints. Basic prescription: Shuigou (GV26), Hegu (LI4), Neiguan (PC6), Zusanli (ST36), Yanglingquan (GB34), Taichong (LR3), Sanyinjiao (SP6). On this basis, 1 to 4 additional acupoints are selected based on the two most severely affected joint areas. Needle selection: The acupuncture needles (40 or 75 mm x 0.25 mm gauge, and 40 mm x 0.18 mm gauge, Huatuo, Suzhou, China) will be used. An electroacupuncture stimulator (SDZ-V, Huatuo, Suzhou, China) will be used, delivering alternating frequencies of 2 Hz/10 Hz with no more than four electrode pairs simultaneously.
PROCEDUREAuricular Acupressure Group
The auricular acupressure protocol is formed by combining the basic auricular point prescription and the auricular point prescription corresponding to the affected joints. The basic points include Shenmen, Sympathetic, Endocrine, and Subcortex, while the additional points are selected by the acupuncturist based on the 1-2 joint regions with the most pain as reported by the patient. Once identified, Vaccaria seed (Zhongyan Taihe, Beijing, China) is taped onto the points until the patient perceives a distinct sensation of soreness or tenderness. Participants will be instructed to apply pressure to each ear three times per day, pressing each side for approximately 3 minutes per session. The auricular patches will be removed 2 to 4 days after during a follow-up visit at the clinic.
Sponsors
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed breast cancer, stage I-IV, according to the AJCC Cancer Staging Manual (8th edition); * Aged 18-75 years; * Experiencing joint pain attributed to endocrine therapy, including localized or generalized joint pain, with symptoms persisting for at least 1 week; * Completion of all planned surgeries, chemotherapy, and radiotherapy, with a scheduled continuation of endocrine therapy for at least 1 additional year; * Self-reported worst joint pain score of ≥3 on a 0-10 Visual Analogue Scale (VAS) during the past week; * Life expectancy ≥1 year; * Voluntarily sign the informed consent.
Exclusion criteria
* Bone metastases involving the same site as the affected joint attributed to endocrine therapy; * History of fracture or surgery involving the affected joints within the past 6 months; * Implanted electronic medical devices; * Not suitable for acupuncture, including but not limited to bleeding tendencies (e.g. coagulation disorders or purpura) or local skin lesions at the intended acupoint sites.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Worst Pain score of the Brief Pain Inventory-Short Form | Baseline, 4 weeks, 8 weeks, 12weeks, 16 weeks | A single-item numeric rating scale. Min: 0, Max: 10. Higher scores mean a worse outcome (more severe pain). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The pain severity score of the Brief Pain Inventory-Short Form | Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks | The mean of 4 items (worst, least, average, and pain "now"). Min: 0, Max: 10. Higher scores mean a worse outcome. |
| The pain interference score of the Brief Pain Inventory-Short Form | Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks | The mean of 7 items (general activity, mood, walking, work, relations, sleep, enjoyment). Min: 0, Max: 10. Higher scores mean a worse outcome. |
| The Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) scale | Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks | A scale assessing quality of life in patients receiving endocrine therapy. Min: 0, Max: 76 (for the ES subscale). Higher scores mean a worse outcome. |
| The Patient-Reported Outcomes Measurement Information System Global Health scale (PROMIS Global Health) | Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks | 10 items assessing physical, mental, and social health. Results are typically converted to T-scores. Min: 0, Max: 100(standardized). Higher scores mean a better outcome (better health). |
| The EuroQol 5-Dimension 5-Level (EQ-5D-5L) | Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks | It comprises two primary components: the EQ-5D-5L Index Score and the EQ Visual Analogue Scale (EQ VAS). For the Index Score, values typically range from less than 0 to 1, where higher scores indicate better health-related quality of life. The EQ VAS provides a self-rated assessment of overall health on a scale from 0 to 100, where higher scores represent better self-rated health. |
| Credibility/Expectancy Questionnaire（CEQ） | Baseline, 4 weeks, 8 weeks | It utilizes two different scoring formats-a 1-9 Likert scale and a 0%-100% percentage scale. The composite score for a single factor typically ranges from a minimum of 3 to a maximum of 27. Higher scores indicate a better outcome, representing a higher psychological expectation for symptom improvement. |
Countries
China
Contacts
CONTACTLi Li
CONTACTJing Xue
STUDY_CHAIRLi Li
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Outcome results
None listed